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    NDC 42192-0614-10 PHENYTOIN SODIUM 50 mg/mL Details

    PHENYTOIN SODIUM 50 mg/mL

    PHENYTOIN SODIUM is a INTRAMUSCULAR; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acella Pharmaceuticals, LLC. The primary component is PHENYTOIN SODIUM.

    Product Information

    NDC 42192-0614
    Product ID 42192-614_a6e2c6d9-fd28-4276-a578-976aba15cbf0
    Associated GPIs 72200030052005
    GCN Sequence Number 004528
    GCN Sequence Number Description phenytoin sodium VIAL 50 MG/ML INTRAVEN
    HIC3 H4B
    HIC3 Description ANTICONVULSANTS
    GCN 17200
    HICL Sequence Number 001878
    HICL Sequence Number Description PHENYTOIN SODIUM
    Brand/Generic Generic
    Proprietary Name PHENYTOIN SODIUM
    Proprietary Name Suffix n/a
    Non-Proprietary Name PHENYTOIN SODIUM
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name PHENYTOIN SODIUM
    Labeler Name Acella Pharmaceuticals, LLC
    Pharmaceutical Class Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA040573
    Listing Certified Through 2024-12-31

    Package

    NDC 42192-0614-10 (42192061410)

    NDC Package Code 42192-614-10
    Billing NDC 42192061410
    Package 10 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIAL
    Marketing Start Date 2021-12-30
    NDC Exclude Flag N
    Pricing Information N/A